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  • September

Alkermes depression drug placed on FDA's fast track

American Pharmacy News Reports | Sep 2, 2017
Fast-track status enables Alkermes to deliver portions of the NDA as completed on a rolling basis.

Soliciting marketing approval for a medication addressing major depressive disorder, Alkermes PLC recently began a rolling submission of a New Drug Application regarding its ALKS 5461 product, expecting completion by the end of 2017. Read More »

Wuxi Biologics to pay Ligand $2 million in licensing transfer

American Pharmacy News Reports | Sep 2, 2017
Ligand's OmniAb platform is a patented model containing three transgenic platforms for creating human antibodies.

Drug developer Ligand Pharmaceuticals Inc. (LGND) of San Diego, California will receive $2 million plus royalties and other benefits from WuXi Biologics in a new licensing agreement involving an antibody technology, company officials announced recently. Read More »

C. R. Bard wins FDA approval for Lutonix in renal patients

American Pharmacy News Reports | Sep 2, 2017
Lutonix also obtained previous agency approval for other artery disorders.

Murray Hill, New Jersey-based surgical product producer and marketer C. R. Bard recently obtained premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Lutonix 035 drug coated balloon PTA catheter (DCB). Read More »

Reduction in antibiotic prescriptions in Massachusetts leads national trend

Carol Ostrow | Sep 2, 2017

Newly compiled data from the Blue Cross Blue Shield Association indicates that the nation — particularly the state of Massachusetts — has substantially lowered the number of outpatient prescriptions for antibiotics, association sources announced recently from Boston. Read More »

Albertsons stocks flu shots, other vaccines for coming season

American Pharmacy News Reports | Sep 4, 2017
Albertsons recommends consumers curtail contagion by keeping annual immunization on their radar.

Albertsons Cos. plans on continued care for its customers as flu season approaches, reporting from its Boise, Idaho base that influenza vaccines are now in stock. Read More »

Genentech's Actemra receives approval from FDA to treat CRS patients

American Pharmacy News Reports | Sep 4, 2017

Genentech, a member of the Roche Group, recently announced that its drug Actemra received approval from the U.S. Food and Drug Administration (FDA). Read More »

BioMarin's pegvaliase accepted for FDA priority review

American Pharmacy News Reports | Sep 4, 2017
Pegvaliase treats adult patients with phenylketonuria (PKU) with uncontrolled blood Phe levels.

BioMarin Pharmaceuticals' Biologics License Application (BLA) for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, has been accepted for Priority Review by the U.S. Food and Drug Administration. Read More »

Research shows benefits of adhering to diabetes medication

American Pharmacy News Reports | Sep 5, 2017
Commercially insured people who remained adherent to their oral diabetes medications experienced fewer emergencies.

Express Scripts, a company that provides pharmacy benefit management services, recently announced research showing significant benefits of adherence to diabetes medications. Read More »

Adamas gains FDA approval for Parkinson’s medication

American Pharmacy News Reports | Sep 5, 2017
Adamas Pharmaceuticals develops treatments for chronic neurologic disorders.

With the goal of treating dyskinesia in certain Parkinson’s disease patients, Adamas Pharmaceuticals of Emeryville, California recently obtained U.S. Food and Drug Administration approval for its Gocovri (amantadine) extended release capsules. Read More »

Abbott to begin clinical study of Amplatzer device

American Pharmacy News Reports | Sep 5, 2017
Amplatzer was created to correct a common congenital heart defect.

Abbott recently announced the initiation of a pivotal clinical study based in the United States that will assess the safety and efficacy of a modified version of its Amplatzer device. Read More »

Novo Nordisk's Victoza approved for new indication by FDA

American Pharmacy News Reports | Sep 5, 2017
Novo Nordisk’s study showed Victoza reduced the risk of cardiovascular death.

Novo Nordisk recently announced that the U.S. Food and Drug Administration approved a new indication for Victoza, which should help reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease. Read More »

Accorda Therapeutics receives Refusal to File letter for Inbrija

Mark Iandolo | Sep 5, 2017
Problems occurred with the date given for when Acorda's manufacturing site would be ready for inspection.

Accorda Therapeutics Inc. recently announced that the U.S. Food and Drug Administration (FDA) provided a Refusal to File (RTF) letter regarding the company’s New Drug Application (NDA) for Inbrija, an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Read More »

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